January 16, 2017 — Fujifilm Medical Systems has informed the U.S. Food and Drug Administration (FDA) of its plans to remove its legacy 250/450 duodenoscope models from clinical use. This is based on the limited number currently in use and issues related to reprocessing of these devices leading to reports of multi‐drug resistant bacteria on endoscopes used for endoscopic retrograde cholangiopancreatogram (ERCP) procedures.
On Jan. 13, 2017, Fuji notified its customers it will replace the 250/450 duodenoscope models with the newer ED-530XT model, in addition to necessary accessories (i.e. brushes) at no cost.
In December 2015, Fuji issued validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. At that time, the FDA recommended that users and healthcare facilities apply the revised reprocessing instructions for the ED-530XT duodenoscope to reprocess the older 250/450 duodenoscope models while formal validation testing continued for these particular models.
Read letter sent to Fujifilm customers at www.fujifilmusa.com/products/medical/endoscopy/pdf/urgent_field_correction_ed_530XT.pdf
The validated manual reprocessing procedures for the ED-530XT duodenoscope outlined in a December 2015 FDA safety communication remain the same. Healthcare facilities should continue to use these validated instructions when reprocessing Fuji ED-530XT duodenoscope models. The validated reprocessing instructions when followed correctly, are intended to effectively clean and high-level disinfect the Fuji ED-530XT duodenoscope.
The FDA recommendations for healthcare facilities and staff include:
• Remove from circulation and return your facility’s 250/450 duodenoscope models to Fuji as outlined in Fuji’s Customer Notification Letter.
• Train appropriate staff on Fuji’s validated reprocessing instructions for the ED-530XT model and implement them as soon as possible.
• Implement the reprocessing procedures for Fuji’s ED-530XT duodenoscope in accordance with the manufacturer’s reprocessing instructions issued in December 2015.
• Immediately remove from service to assess, repair and/or replace any duodenoscope that shows signs of damage. Examples of damage may include: loose parts, damaged channel walls, kinks or bends in tubing, holes in the distal end, or other signs of wear or damage.
• Contact your Fuji sales representative if you have any questions or concerns regarding this removal, a damaged device, or the validated reprocessing instructions for the ED-530XT duodenoscope.
The FDA said it continues to closely monitor the association between reprocessed endoscopes and the transmission of infectious agents by working closely with duodenoscope and automated endoscope reprocessor manufacturers as they validate their reprocessing instructions to a level adequate to clean and high-level disinfect their devices. The FDA also is communicating recommendations to healthcare providers and end users to help mitigate the risk associated with infection transmission and reusable medical devices.
Visit the Infections Associated with Reprocessed Duodenoscopes webpage for a complete listing of actions the agency has taken on this issue. The FDA said it will continue to provide updates as appropriate.